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Dinutuximab Side Effects

In Summary

Commonly reported side effects of dinutuximab include: capillary leak syndrome, sepsis, severe hypokalemia, severe hypotension, severe infusion related reaction, severe thrombocytopenia, SIADH, infusion related reaction, abdominal pain, anemia, back pain, eye disease, fever, hypertension, hypocalcemia, hypokalemia, hyponatremia, hypotension, limb pain, musculoskeletal chest pain, neuralgia, neutropenia, pain, urticaria, and bacteremia. Other side effects include: febrile neutropenia, and peripheral sensory neuropathy. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to dinutuximab: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by dinutuximab. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking dinutuximab, check with your doctor or nurse immediately:

More common:
  • Black, tarry, stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • chills
  • cloudy urine
  • coma
  • confusion
  • convulsions
  • cough or hoarseness
  • decrease or increase in the amount of urine
  • difficult or labored breathing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fainting or lightheadedness
  • fast or irregular heartbeat
  • fever
  • headache
  • hives or welts, itching, or skin rash
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramps
  • nausea or vomiting
  • noisy breathing
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • redness of the skin
  • sore throat
  • stomach pain
  • sweating
  • swelling of the face, hands, ankles, feet, or lower legs
  • tightness in the chest
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common:
  • Back pain
  • bigger, dilated, or enlarged pupils (black part of the eye)
  • burning, numbness, tingling, or painful sensations
  • change in color vision
  • change in the ability to see colors, especially blue or yellow
  • chest pain
  • difficulty seeing at night
  • drooping upper eyelids
  • increased sensitivity of the eyes to sunlight
  • muscle or joint pain
  • nerve pain
  • pain in the arms or legs
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
Incidence not known:
  • Yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with dinutuximab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Diarrhea

For Healthcare Professionals

Applies to dinutuximab: intravenous solution

Cardiovascular

Very common (10% or more): Hypotension (up to 60%), capillary leak syndrome (up to 40%), hemorrhage (up to 17%) (including gastrointestinal hemorrhage, hematochezia, rectal hemorrhage, hematemesis, upper gastrointestinal hemorrhage, hematuria, hemorrhage urinary tract, renal hemorrhage, epistaxis, respiratory tract hemorrhage, disseminated intravascular coagulation, catheter site hemorrhage, hemorrhage, hematoma), hypertension (up to 14%), tachycardia (up to 19%) (including tachycardia, sinus tachycardia)Very common (10% or more): Hypotension (up to 60%), capillary leak syndrome (up to 40%), hemorrhage (up to 17%) (including gastrointestinal hemorrhage, hematochezia, rectal hemorrhage, hematemesis, upper gastrointestinal hemorrhage, hematuria, hemorrhage urinary tract, renal hemorrhage, epistaxis, respiratory tract hemorrhage, disseminated intravascular coagulation, catheter site hemorrhage, hematoma), hypertension (up to 14%), tachycardia (up to 19%) (including tachycardia, sinus tachycardia)[Ref]

Dermatologic

Very common (10% or more): Urticaria (up to 37%)[Ref]

Gastrointestinal

Very common (10% or more): Pain (up to 85%) (including gingival pain, proctalgia, oropharyngeal pain, abdominal pain, abdominal pain upper), vomiting (up to 46%), diarrhea (up to 43%), nausea (up to 10%)[Ref]

Genitourinary

Very common (10% or more): Pain (up to 85%) (including bladder pain), proteinuria (up to 16%)[Ref]

Hematologic

Very common (10% or more): Thrombocytopenia (up to 66%), lymphopenia (up to 62%), anemia (up to 51%), neutropenia (up to 39%)[Ref]

Hepatic

Very common (10% or more): Increased alanine aminotransferase (up to 56%), increased aspartate aminotransferase (up to 28%)[Ref]

Hypersensitivity

Very common (10% or more): Infusion reactions (up to 66%)[Ref]

Immunologic

Very common (10% or more): Patients developing anti-drug antibodies to dinutuximab (up to 18%), sepsis (up to 18%), device related infection (up to 16%)[Ref]

Local

Very common (10% or more): Pain (up to 85%) (including infusion related pain)[Ref]

Metabolic

Very common (10% or more): Hyponatremia (up to 58%), hypokalemia (up to 43%), hypoalbuminemia (up to 33%), hypocalcemia (up to 27%), hypophosphatemia (up to 20%), hyperglycemia (up to 16%), hypertriglyceridemia (up to 16%), decreased appetite (up to 15%), hypomagnesemia (up to 12%)[Ref]

Musculoskeletal

Very common (10% or more): Pain (up to 85%) (including arthralgia, back pain, bone pain, chest pain, facial pain, musculoskeletal chest pain, myalgia, nick pain, pain in extremity)[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (up to 13%)[Ref]

Ocular

Frequency not reported: Blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, papilledema loss of vision[Ref]

Other

Very common (10% or more): Pain (up to 85%) (including abdominal pain, abdominal pain upper, arthralgia, back pain, bladder pain, bone pain, chest pain, facial pain, gingival pain, infusion related reaction, musculoskeletal chest pain, myalgia, neck pain, neuralgia, oropharyngeal pain, pain in extremity, proctalgia), pyrexia (up to 72%), edema (up to 17%), increased weight (up to 10%)[Ref]

Renal

Very common (10% or more): Increased serum creatinine (up to 15%)[Ref]

Respiratory

Very common (10% or more): Hypoxia (up to 24%)[Ref]

General

The most common adverse drug reactions (25% or more) are pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia

References

1. "Product Information. Unituxin (dinutuximab)." United Therapeutics Corporation, Silver Spring, MD.

Not all side effects for dinutuximab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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